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Valneva in talks with EU about 60 million vaccine doses

French Valneva SE announced it is in advanced discussions with the European Commission (EC) for the supply of up to 60 million doses of its COVID-19 vaccine, VLA2001.

VLA2001 is currently the only inactivated vaccine candidate in clinical trials against COVID-19 in Europe. The vaccine candidate entered Phase I/II dose finding and safety studies in December 2020 and Valneva expects to report initial safety and immunogenicity data in April 2021. If clinical development is successful, an initial approval may be granted in the second half of 2021.

In September 2020, Valneva announced a COVID-19 vaccine partnership with the UK government for the supply of up to 190 million doses of its inactivated vaccine candidate, VLA2001. Under the partnership agreement, if vaccine development is successful, Valneva will provide the UK government with 60 million doses in the second half of 2021.

VLA2001 consists of inactivated whole virus particles of SARS-CoV-2 with high S-protein density, in combination with two adjuvants, alum and CpG 1018. This adjuvant combination has consistently induced higher antibody levels in preclinical experiments than alum-only formulations and shown a shift of the cellular immune response towards Th1.

VLA2001 is produced on Valneva’s established Vero-cell platform. The process, which has already been upscaled to final industrial scale, includes inactivation with BPL to preserve the native structure of the S-protein. CpG 1018 is a component of the US FDA-approved HEPLISAV-B® vaccine. VLA2001 is expected to conform with standard cold chain requirements (2 degrees to 8 degrees Celsius).